Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors

• Sponsor: Yakult Honsha Co., LTD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00364143
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Duration (Months): 57
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is safe and effective in the treatment of advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: IHL-305 (irinotecan liposome injection)	Phase 1

Detailed Description

This is a Phase I dose-escalation study of intravenous administration of IHL-305 in patients with advanced solid tumors. Patients will receive IHL-305 as an intravenous infusion over 60 minutes on Day 1 followed by a 27-day observation period for a total of 28 days (4 weeks) per cycle. Two patient populations will be evaluated separately; patients with UGT1A1*28 genotype homozygous wild-type (wt/wt) and heterozygous (wt/28) variants as one group, and patients with UGT1A128 homozygous variant (*28/*28) as another group.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors
• Study Start Date: Sep 1, 2006
• Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. Incidence of dose-limiting toxicity within 28 days of treatment administration for patients with UGT1A1*28 genotype (wt/wt and wt/*28) []

2. determination of maximum tolerated dose (MTD) and recommended Phase 2 dose for patients with UGT1A1*28 genotype (wt/wt and wt/*28) []

Secondary Outcome Measures

1. Tumor shrinkage per Response Evaluation Criteria in Solid Tumors (RECIST) every 8 weeks/2 cycles while receiving study drug for patients with UGT1A1*28 genotype (wt/wt and wt/*28) []

2. limited pharmacokinetics (PK) for patients with UGT1A1*28 genotype (wt/wt and wt/*28) []

3. limited incidence and severity of adverse events (AEs) and PK for UGT1A1 homozygous (*28/*28) patients []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed malignant solid tumor and not a candidate for known regimens or protocol treatments of higher efficacy or priority

2. Failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist

3. Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)

4. ECOG performance status of 0, 1, or 2

5. 18 years of age or older

6. Normal organ and bone marrow function as defined by:

• absolute neutrophil count greater than or equal to 1,500 cells/microliter

• platelets greater than or equal to 100,000 cells/microliter

• total bilirubin within normal institutional limits

• AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal (ULN) or less than or equal to 5.0 x ULN in patients with liver metastases

• plasma creatinine less than or equal to 1.5 x institutional ULN OR

• creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

1. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Previously treated with irinotecan, or had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or not recovered from adverse effects due to agents administered more than 4 weeks earlier

2. Receiving any other investigational agent

3. Known brain metastases

4. History of allergic reactions attributed to compounds of similar chemical composition to IHL-305

5. Concurrent serious infections (i.e., requiring an intravenous antibiotic)

6. Pregnant women or women of childbearing potential and not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential; no breast-feeding while on study.

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

8. Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; history of myocardial infarction within one year of study entry; uncontrolled dysrhythmias; or poorly controlled angina.

9. History of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF], greater than or equal to 3 beats in a row); QTc greater than or equal to 450 msec for men and 470 msec for women; or left ventricular ejection fraction (LVEF) less than or equal to 40% by multi-gated acquisition scan (MUGA).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarah Cannon Cancer Center	Nashville	Tennessee	United States	37203
2	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6307

Sponsors and Collaborators

• Yakult Honsha Co., LTD

Investigators

• Principal Investigator: Mace L Rothenberg, M.D., Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00364143
• Other Study ID Numbers: IHL-PRT001
• First Posted: Aug 15, 2006
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by , ,: Cancer; Advanced Solid Tumor; Oncology
• Additional relevant MeSH terms: Irinotecan

Study Results

No Results Posted as of Jul 5, 2019